Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma

Sponsor

University of Salzburg (Other)

Overall Status

Unknown status

CT.gov ID

NCT01016002

Collaborator

Biolitec Pharma Ltd. (Industry)

Enrollment

Locations

Arm

17.5

Patients Per Site

Study Details

Study Description

Brief Summary

The purpose of this study is to assess efficacy and safety of Foscan (temoporfin) photodynamic therapy in the treatment of locally advanced perihilar bile duct carcinoma without distant metastases.

Condition or Disease	Intervention/Treatment	Phase
Non-curative Resectable Bile Duct Carcinoma	Drug: Temoporfin	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II, Open-label, Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma

Study Start Date :

Jan 1, 2006

Anticipated Primary Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention	Drug: Temoporfin Drug treatment: Temoporfin 0.15 mg/kg body weight, intravenous injection within at least 6 min. Laser Treatment: 652nm wavelength; 30 Joules/cm diffusor length ( 200 sec at 150mW/cm diffusor length), within 96 h after Foscan Other Names: Foscan Meso-tetrahydroxyphenyl Chlorin

Arm

Intervention/Treatment

Experimental: Intervention

Drug: Temoporfin

Drug treatment: Temoporfin 0.15 mg/kg body weight, intravenous injection within at least 6 min. Laser Treatment: 652nm wavelength; 30 Joules/cm diffusor length ( 200 sec at 150mW/cm diffusor length), within 96 h after Foscan

Other Names:

Foscan

Meso-tetrahydroxyphenyl Chlorin

Outcome Measures

Primary Outcome Measures

Rate of local response and depth of tumoricidal tissue penetration of Foscan-PDT [post treatment]

Secondary Outcome Measures

Progression-free survival time, overall survival time [Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention]
Toxicity using WHO criteria and criteria for local toxicity in the biliary system [Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

bile duct carcinoma proven by histology in advanced or non-operable stage or tumor extension:

Bismuth type III or IV ( not resectable with R0-margins )
Bismuth type I or II, if resective surgery is contraindicated for old age or poor surgical risk of patient

sufficient general condition to undergo PDT (Karnofsky status > 30%)
age > 19 years
access to common bile duct (either via endoscopy after sphincterotomy or percutaneously after transhepatic drainage),
informed written consent

Exclusion Criteria:

porphyria or other diseases exacerbated by light
known intolerance or allergies to porphyrin derivatives
a planned surgical procedure within the next 30 days
coexisting ophthalmic disease likely to require slit lamp examination within the next 30 days
impaired kidney or liver function (creatinine > 2.5x elevated, INR > 2.2 on vitamin K),
leukopenia ( WBC < 2000/cmm ) or thrombopenia ( < 50000/cmm ),
cytotoxic chemotherapy within the past 4 weeks.
pregnancy ( and safe contraception for 6 months after PDT )
accompanying/complicating disease with very poor prognosis (expected survival < 6 weeks),
proven advanced peritoneal carcinomatosis ( PET scan imaging, ascites positive for tumor cells)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Internal Medicine I, Paracelsus Medical University Salzburg	Salzburg		Austria	5020
2	Internal Medicine Dept., University Medical Center Hamburg-Eppendorf	Hamburg		Germany	20246

Sponsors and Collaborators

University of Salzburg
Biolitec Pharma Ltd.

Investigators

Principal Investigator: Frieder Berr, Prof., MD, Department of Internal Medicine I, Paracelsus Medical University Salzburg, Muellner Hauptstrasse 48, 5020, Salzburg, Austria
Principal Investigator: Lohse A, Prof., MD, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany